Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors
This is a Phase 1/2 open-label study. In the Phase 1 part of the study, PX-866 was given in
combination with docetaxel to patients with incurable locally advanced, recurrent or
metastatic cancer.
Phase 2 of the study is an open-label, randomized evaluation of the antitumor activity and
safety of PX-866, administered at the MTD/RD identified in Phase 1 (8mg daily), in
combination with docetaxel versus docetaxel alone in patients with locally advanced,
recurrent, or metastatic NSCLC (Group 1) or patients with locally advanced, recurrent, or
metastatic SCCHN (Group 2).
Group 1 (patients with locally advanced, recurrent, or metastatic NSCLC) is now closed to
enrollment.
All treatments will be administered on a 21-day cycle. Docetaxel 75 mg/m2 will be
administered IV on Day 1 of each 21-day cycle. PX-866 will be administered orally or via PEG
tube (if applicable) once per day on Days 1 to 21 of all treatment cycles in patients
randomized to the treatment arm containing PX-866.
Patients will be evaluated for progression approximately every 6 weeks. Patients with stable
disease (SD) or better, per investigator assessment, will receive repeat cycles of treatment
on a 21-day schedule until disease progression, unacceptable toxicity or withdrawal of
consent.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
42 days
No
United States: Institutional Review Board
PX-866-002
NCT01204099
September 2010
February 2013
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Southwest Cancer Care | Poway, California 92064 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
New York University Medical Center | New York, New York 10016 |
Washington University | St. Louis, Missouri 63110 |
Bay Area Cancer Research Group, LLC | Concord, California 94520 |
Ut Southwestern Medical Center | Dallas, Texas 75390 |
Columbia University Medical Center | New York, New York 10032 |
Beth Israel Hospital | New York, New York 10003 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
New Mexico Cancer Care Alliance | Albuquerque, New Mexico 87106 |
Yakima Valley Memorial Hospital/North Star Lodge | Yakima, Washington 98902 |
Northwest Cancer Specialists | Portland, Oregon 97225 |
Columbia Basin Hematology & Oncology | Kennewicke, Washington 99336 |
John Hopkins University | Baltimore, Maryland 21231 |
Mary Crowley Cancer Center | Dallas, Texas 75246 |
Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas, Texas 75246 |
Marin Cancer Care, Inc. | Greenbrae, California 94904 |
Virginia Cancer Specialists | Fairfax, Virginia |
Bronx Lebanon Hospital | Bronx, New York 11203 |
Eastern Colorado Health Care System - Denver VA | Denver, Colorado 80220 |
Cancer Center of Pasco-Pinellas | Holiday, Florida 34619 |
New York Oncology, Hematology | Latham, New York 12110 |
Kaiser Permanante Northwest | Portland, Oregon 97227 |
Texas Oncology - South Austin | Austin, Texas 78745 |
Oncology and Hematology Associates of SW Virginia, DBA Blue Ridge Cancer Care | Christiansburg, Virginia 24073 |
Medical Oncology Associates | Spokane, Washington 99208 |